"The benefits of compounds are uncertain, and the patient safety issues
are profound," said CompPharma's President Joseph Paduda. "Insurance
companies and other work comp payers are struggling with the increase in
compounded drug prescriptions and their high costs. Member PBMs
researched the safety, efficacy, pricing, regulation, and reimbursement
of compounds to help the industry better understand the possible
benefits and address he risks."

The analysis found no clinical evidence that topical compounds commonly
used in workers' compensation are more effective than commercially
available, manufactured drugs. Additionally, the research identified
significant patient safety concerns, including inconsistent regulatory
oversight, inaccurate dosing in sterile preparations as well as
sterility concerns, duplicate drug ingredients and excessive
concentrations of drugs in topical compounds.

"Topical compounds frequently contain duplicative ingredients such as
two muscle relaxants and/or two non-steroidal anti-inflammatories
(NSAIDS)," said Phil Walls, RPh, the paper's lead author. "There is no
clinical rationale for these duplications and there are risks of adverse
effects."

Bulk production of compounds raises questions about whether pharmacies
are compounders or manufacturers. "Compounds should be prescribed and
prepared for an individual with unique needs such as the inability to
swallow the manufactured product or an allergy to ingredients in the
manufactured drug," Walls said. "But some pharmacies create bulk batches
of topical compounds and then recommend that physicians prescribe them.
Is this compounding or manufacturing?" Walls noted that the Federal Drug
Administration regulates pharmaceutical manufacturing but not compounded
drugs.

CompPharma recommends prescriptions for compounds require
pre-authorization to ensure they are used only when there is a
patient-specific requirement, as described above. The pre-authorization
request should require:

Evidence of effectiveness and safety for topical compounds, such
as study with a randomized controlled trial published in a
peer-reviewed medical journal.

A letter of medical necessity demonstrating conventional therapy has
been tried and failed.

About CompPharma

Established by industry consultants Joseph Paduda and Helen Knight,
CompPharma, LLC is a consortium of PBMs active in workers compensation.
Member PBMs are Catamaran, Express Scripts, HealthCare Solutions,
Healthesystems, myMatrixx, and Progressive Medical & PMSI. More
information is available at www.comppharma.com.